medical Class II Updated 2020-04-01

Intellijoint Surgical, Inc. recalls Intellijoint Navigation System, Software Application, IJK1 (

Recalled Product

Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.


Hazard / Issue

During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.
View official government recall

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